We are seeking a skilled Fill Finish Engineer to support the technical transfer of processes and products into GMP manufacturing at our facility. This role requires a strong understanding of fill & finish processes and excellent collaboration skills to work effectively with project teams. The ideal candidate will be responsible for assisting in the creation of key documentation, ensuring project milestones are tracked, and providing hands-on support in cleanroom environments.
Key Responsibilities:
* Partner with GMP manufacturing and Capital project teams as the Fill Finish SME in a greenfield fill & finish process
* Oversee automation readiness, ensuring system integration with filling lines and compliance with validation requirements
* Document protocols, engineering tests, and validation reports to ensure compliance with regulatory and client requirements
* Working closely with the Fill Finish team ensure project milestones are achieved and attending reoccurring and adhoc meetings as required
* Collect and trend process data for external (client) and internal review
* Support MES recipe startup, debugging, and documentation updates to align with process optimization efforts
* Assist with training GMP Manufacturing staff on Client processes
* Provide deviation resolution and qualification support by addressing process deviations, troubleshooting startup and PQ issues, and coordinating with the client and vendors to maintain project timelines
* Assist Clients in regulatory filing support as a process SME
* Support MFG team with hands on cleanroom guidance as necessary
Required Skills and Qualifications:
* B.S. in Chemical Engineering, Chemistry, Biology, Life Sciences, or related field with 3+ years of experience in fill & finish validation and process engineering
* Expertise in sterile filtration, washer and tunnel validation, filling and capping operations, and isolator qualification
* Experience with automation and process integration, including MES recipe development and debugging
Benefits:
* Candidate should have analytical skills, negotiation skills, relationship building skills and interpersonal awareness
* Candidate should have agility, active listening, needs assessment and rational persuasion